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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 257 - Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC?
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257 - Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    APS promoting supplements purely for the maintenance of normal health do not require PAAB review. Note that APS directed to healthcare professionals (or patients through healthcare professionals) relating to DIN, NPN, and DIN-HM products for more specific uses require PAAB review. For example, APS which promote the use of a Vitamin supplement for maintenance of strong bones would require PAAB review.

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